Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296140
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2006-02-22
Brief Title:
Implementing Evidence in the Detection and Treatment of Post Stroke Depression
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Implementation Evidence in the Detection and Treatment of Post-stroke Depression
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post Stroke Depression PSDis a high volume condition with negative impact on patient recovery after stroke The primary aim of this study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and started on treatment for PSD
The secondary aim is evaluate whether a patient-based self-management intervention provides any additional benefit compared to usual care
The secondary aim is evaluate whether a patient-based self-management intervention provides any additional benefit compared to usual care
Detailed Description:
Objective
The investigators immediate objective is to test a system intervention to evaluate which aspects of the intervention are critical to improving the quality of care for veterans with PSD and to refine it to prepare for the investigators long-term objective a multi-site study across multiple facilities and Veteran Integrated Service Networks VISNs To address the immediate objective the investigators will evaluate two specific study aims using a quasi-experimental design comparing improvement in depression screening and treatment in veteran stroke survivors receiving care at two facilities receiving the intervention
The primary aim of the study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and treated for PSD The system intervention is based on extending the use of the current depression performance measure that mandates yearly depression screening in VA primary care clinics to target veteran stroke survivors following-up in Veterans Administration VA Primary Care or Neurology clinics within six months of stroke The primary outcome is the effect of the intervention on depression screening and treatment rates The secondary aim of the study is to evaluate whether a patient-based self-management intervention provides additional benefit beyond the system intervention alone in improving patient depression symptoms quality of life and self-efficacy compared to usual post-stroke care Subjects for the secondary aim will be recruited from the two intervention sites and will be randomized stratified by site to the patient intervention or usual care
HypothesesKey Research Questions
Specific Aim 1 To determine whether the system implementation intervention improves a detection and b guideline-adherent treatment of PSD Aim 1 Hypotheses Compared to the base rate of PSD screening and treatment at the two intervention facilities the system intervention will result in at least a 25 increase in a The proportion of Veterans screened for PSD in the first six months after stroke and b The proportion of Veterans with PSD that receive guideline-adherent depression treatment
Specific Aim 2 To determine the effect of a patient self-management intervention in improving a guideline-adherent treatment of PSD and b patient-centered outcomes after stroke Aim 2 Hypotheses Compared to Veterans receiving usual post-stroke care Veterans receiving the self-management intervention will have a fewer depression symptoms and b improved quality of life and reduced health-related fears
Research Plan
Specific Aim 1 The investigators developed clinical teams at the two intervention facilities and worked with these front-line providers to develop two depression reminders a screening reminder used by clinic intake personnel and a provider reminder triggered by any positive screen The reminders were tailored to the clinical system at each site The investigators are gathering administrative and chart review data on Veterans with ischemic stroke hospitalized at any of the VISN 8 or 11 VA Medical Center VAMC facilities during the 18-month cohort enrollment period These data allow us to identify patients who follow up in either Primary Care or Neurology identify whether they were screened and the screening result and identify actions taken in response to a positive screen Chart review allows us to examine depression screening and treatment that takes place even if the screening reminder is not used The investigators will compare these data during the study period to chart review data for the 12 months prior to study initiation in both Primary Care and Neurology clinics at each site and to administrative data for all VISN 8 and 11 facilities estimated number of patients in both VISNs is 822 For Specific Aim 2 the investigators are recruiting hospitalized Veterans for ischemic stroke at the Indianapolis or Gainesville VAMC age 18 or older able to speak and understand English no severe cognitive impairments access to a telephone willing to follow-up at VA outpatient care willing to participate in interviews and life expectancy of at least six months For Aim 2 the investigators plan to recruit 75 stroke patients into the Aim 2 self-management cohort
Methodology
Aim 1 All data will be obtained from chart review and from the VA administrative databases that are part of the usual clinic care of the patients These data include International Classification of Diseases ICD-9 codes extracted from Patient Treatment File main as well as basic demographics ie age gender race ethnicity depression screening results antidepressants prescribed and number and type of outpatient follow-up appointments in the six months after stroke All outcome data for this aim will be collected from electronic medical records
Aim 2 Data for the self-management program will be collected via patient interviews during the course of the study The baseline interview will take place prior to hospital discharge or within two weeks of discharge Two other interviews for outcome assessment will be done by phone at three and six months post-stroke
Intervention patients will also receive a self-management program over the first six months post-stroke The program consists of six sessions delivered either in person or by phone and four additional follow-up calls to assess goal-setting behaviors and study outcomes Based upon the investigators earlier work patients have expressed an interest in the following topics expectations after stroke negativepositive thinking fears creating a daily schedule follow-up care communication with providers adaptingcoping with disabilities community resources and communication with caregivers These topics will be addressed in the six sessions
Control patients will get baseline three and six-month interviews with the same outcome assessments They will be provided American Stroke Association printed literature about stroke risk factors warning signs and community resources They will receive one individual session prior to discharge or within two weeks of discharge focusing on stroke symptoms and risk factor education They will receive the same number of calls at similar frequency to the intervention patients but the calls will generically cover how they are doing since their stroke and will not address goal setting post-stroke behaviors or self-management strategies
The primary outcome for the patient self-management intervention is depression symptoms Patient Health Questionnaire-9 PHQ-9 score Secondary outcomes include depression treatment quality of life measured by the Stroke-specific Quality of Life SS-QOL scale self-efficacy fear of injury and stroke outcomes patient-reported modified Rankin scale
The investigators immediate objective is to test a system intervention to evaluate which aspects of the intervention are critical to improving the quality of care for veterans with PSD and to refine it to prepare for the investigators long-term objective a multi-site study across multiple facilities and Veteran Integrated Service Networks VISNs To address the immediate objective the investigators will evaluate two specific study aims using a quasi-experimental design comparing improvement in depression screening and treatment in veteran stroke survivors receiving care at two facilities receiving the intervention
The primary aim of the study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and treated for PSD The system intervention is based on extending the use of the current depression performance measure that mandates yearly depression screening in VA primary care clinics to target veteran stroke survivors following-up in Veterans Administration VA Primary Care or Neurology clinics within six months of stroke The primary outcome is the effect of the intervention on depression screening and treatment rates The secondary aim of the study is to evaluate whether a patient-based self-management intervention provides additional benefit beyond the system intervention alone in improving patient depression symptoms quality of life and self-efficacy compared to usual post-stroke care Subjects for the secondary aim will be recruited from the two intervention sites and will be randomized stratified by site to the patient intervention or usual care
HypothesesKey Research Questions
Specific Aim 1 To determine whether the system implementation intervention improves a detection and b guideline-adherent treatment of PSD Aim 1 Hypotheses Compared to the base rate of PSD screening and treatment at the two intervention facilities the system intervention will result in at least a 25 increase in a The proportion of Veterans screened for PSD in the first six months after stroke and b The proportion of Veterans with PSD that receive guideline-adherent depression treatment
Specific Aim 2 To determine the effect of a patient self-management intervention in improving a guideline-adherent treatment of PSD and b patient-centered outcomes after stroke Aim 2 Hypotheses Compared to Veterans receiving usual post-stroke care Veterans receiving the self-management intervention will have a fewer depression symptoms and b improved quality of life and reduced health-related fears
Research Plan
Specific Aim 1 The investigators developed clinical teams at the two intervention facilities and worked with these front-line providers to develop two depression reminders a screening reminder used by clinic intake personnel and a provider reminder triggered by any positive screen The reminders were tailored to the clinical system at each site The investigators are gathering administrative and chart review data on Veterans with ischemic stroke hospitalized at any of the VISN 8 or 11 VA Medical Center VAMC facilities during the 18-month cohort enrollment period These data allow us to identify patients who follow up in either Primary Care or Neurology identify whether they were screened and the screening result and identify actions taken in response to a positive screen Chart review allows us to examine depression screening and treatment that takes place even if the screening reminder is not used The investigators will compare these data during the study period to chart review data for the 12 months prior to study initiation in both Primary Care and Neurology clinics at each site and to administrative data for all VISN 8 and 11 facilities estimated number of patients in both VISNs is 822 For Specific Aim 2 the investigators are recruiting hospitalized Veterans for ischemic stroke at the Indianapolis or Gainesville VAMC age 18 or older able to speak and understand English no severe cognitive impairments access to a telephone willing to follow-up at VA outpatient care willing to participate in interviews and life expectancy of at least six months For Aim 2 the investigators plan to recruit 75 stroke patients into the Aim 2 self-management cohort
Methodology
Aim 1 All data will be obtained from chart review and from the VA administrative databases that are part of the usual clinic care of the patients These data include International Classification of Diseases ICD-9 codes extracted from Patient Treatment File main as well as basic demographics ie age gender race ethnicity depression screening results antidepressants prescribed and number and type of outpatient follow-up appointments in the six months after stroke All outcome data for this aim will be collected from electronic medical records
Aim 2 Data for the self-management program will be collected via patient interviews during the course of the study The baseline interview will take place prior to hospital discharge or within two weeks of discharge Two other interviews for outcome assessment will be done by phone at three and six months post-stroke
Intervention patients will also receive a self-management program over the first six months post-stroke The program consists of six sessions delivered either in person or by phone and four additional follow-up calls to assess goal-setting behaviors and study outcomes Based upon the investigators earlier work patients have expressed an interest in the following topics expectations after stroke negativepositive thinking fears creating a daily schedule follow-up care communication with providers adaptingcoping with disabilities community resources and communication with caregivers These topics will be addressed in the six sessions
Control patients will get baseline three and six-month interviews with the same outcome assessments They will be provided American Stroke Association printed literature about stroke risk factors warning signs and community resources They will receive one individual session prior to discharge or within two weeks of discharge focusing on stroke symptoms and risk factor education They will receive the same number of calls at similar frequency to the intervention patients but the calls will generically cover how they are doing since their stroke and will not address goal setting post-stroke behaviors or self-management strategies
The primary outcome for the patient self-management intervention is depression symptoms Patient Health Questionnaire-9 PHQ-9 score Secondary outcomes include depression treatment quality of life measured by the Stroke-specific Quality of Life SS-QOL scale self-efficacy fear of injury and stroke outcomes patient-reported modified Rankin scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None